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A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01382212
First received: June 24, 2011
Last updated: November 8, 2016
Last verified: November 2016

June 24, 2011
November 8, 2016
October 2011
April 2015   (final data collection date for primary outcome measure)
Percentage of Subjects With Hypercalcemia [ Time Frame: Day 1 to Week 12 ] [ Designated as safety issue: Yes ]
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).
Hypercalcemia [ Time Frame: Every 2 weeks during the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
Incidence of hypercalcemia (two consecutive, post baseline corrected calcium measures greater than 10.2 mg/dL). This data will be gathered via blood draws.
Complete list of historical versions of study NCT01382212 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ] [ Designated as safety issue: No ]
  • Hemoglobin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Hematocrit: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Red Blood Cells: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
  • Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
  • Alkaline Phosphatase: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Total Protein and Albumin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
  • Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    n=subjects with evaluable Baseline and Post-baseline data for each parameter.
  • Osteocalcin: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Adverse Events [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
  • Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: Baseline (Day 1) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.
  • Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    Blood pressure was measured after the subject had been sitting for at least 3 minutes.
  • Heart Rate: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
    Heart rate was measured after the subject had been sitting for at least 3 minutes.
  • Oral Body Temperature: Mean Change From Baseline to Final Visit [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Number of Subjects With Potentially Clinically Significant Physical Examination Findings [ Time Frame: Baseline (Day 1) and Final Visit (up to Week 12) ] [ Designated as safety issue: Yes ]
  • Intact parathyroid hormone (iPTH) [ Time Frame: Every 2 weeks during the 12 week dosing period, up to week 12 ] [ Designated as safety issue: No ]
    Proportion of subjects who achieve 2 consecutive iPTH values between 150 to 300 pg/mL (or greater than or equal to 30% reduction from baseline in iPTH). This data will be gathered via blood draws.
  • Safety Measures [ Time Frame: During the 12 week dosing period, up to week 12 ] [ Designated as safety issue: Yes ]
    Safety to be assessed through adverse events, changes from baseline in chemistry and hematology lab variables, electrocardiogram (ECG), and changes from baseline in vital signs and physical examinations.
Not Provided
Not Provided
 
A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End-Stage Renal Disease
  • Secondary Hyperparathyroidism
Drug: paricalcitol
Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
Other Name: ABT-358, Zemplar
Experimental: Paricalcitol
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Intervention: Drug: paricalcitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
  • Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
  • For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:

    • A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
    • A phosphorus value ≤ 6.5 mg/dL
    • An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

Exclusion Criteria:

  • Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
  • Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
  • Subject has had a parathyroidectomy within 12 weeks prior to Screening
  • Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
  • Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
  • Subject is receiving cinacalcet at the time of Screening
Both
10 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany,   Portugal,   United Kingdom,   United States
 
NCT01382212
M11-612, 2013-002610-13
No
Not Provided
Not Provided
AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Ann Eldred, MD AbbVie
AbbVie
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP